Implementation Strategy for a Breastfeeding Guideline in Primary Care

This study has been completed.

Sponsor:

Gerencia de Atención Primaria, Madrid

ClinicalTrials.gov Identifier:

NCT01474096

First Posted: November 18, 2011

Last Update Posted: April 9, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.

determining whether the use of implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding CPG in primary care is more effective than the usual practice of mere circulation.

Protection and promotion of breastfeeding is considered a priority in Europe where only 22% of children less than 6 months old are exclusively breastfed. In Spain this percentage reaches 24.8% but in our city it falls to 18.26%. Various studies emphasise that the improvement of these results falls upon the training of health professionals. Following the recommendations of a breastfeeding guide can modify professional practice and improve results with respect to patients.

Aim:to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.

Method/Design: The present work involves a community, clinical trial, randomised by clusters in Primary Health Care Centres in Madrid Region (Spain). The project aims at determining whether the use of implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding CPG in primary care is more effective than the usual practice of mere circulation.

Number of patients required will be 240 (n=120 in the intervention group and control group), all mothers of children born during the study period (6 months), who come to the health centre on the first visit of child attention programme and give their consent to participate.

The main outcome variable is age at which breastfeeding ceases; secondary outcome variables include sex, age, educational level.

Analysis of main effectiveness will be done, comparing the proportion of patients with breastfeeding completed at 6 months in the two study groups. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

Child, Adult, Senior

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Mothers of children born during the study period (6 months)

Mothers who come to the health centre on 1st visit (child attention programme)

Mothers who give their consent to participate.

Exclusion Criteria:

Breastfeeding Contraindications

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474096